Statistical Techniques for Streamlining Medical Device Design Verification

Medical Device Design VerificationMany techniques can be employed in order to simplify formal verification testing. These techniques expedite the product development process and reduce cost. During verification planning, the required sample size (and therefore the number of devices that need to be built prior to production), can be minimized by the choice of verification method.

Continue reading »

Taimoor Khan

FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

FDA Action Plan for AI/MLArtificial intelligence (AI) and machine learning (ML) technologies have a huge potential to change the way we look at our current health care practices. AI/ML enable new insights derived from the huge amount of data that is collected every day in the health care sector. This blog provides an overview of the FDA action plan for AI/ML in software as a medical device and lists some best practices.

Continue reading »

Astero StarFish

15 Favorite Reads from 2021

Favorite Reads from 2021This blog is inspired by a LinkedIn post from Arash Samimi and the upcoming holiday break.
“I often think of reading books as a means to create a worldview. I want to know what the world looks like today, how we got here and how we can do better tomorrow. The world opportunities and challenges are infinite. It is a gigantic puzzle. That being said, in 2020, I tried to diversify my readings toward creating a big picture of the world – from leadership to technology, retirement, empowerment, society, education, data and startups. Here are 8 of the books I read in 2020.
Book suggestions?”
Our content team took Arash’s idea and offer up fifteen favorite reads from 2021. In no particular order, their selections cover business, fiction, biographies, self-improvement and create a StarFish worldview.

Continue reading »

Astero StarFish

Our 10 most read medical device commercialization blogs of 2021

 medical device commercialization blogsTwo new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog topics. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.

Continue reading »

Glen Farrell

Five Steps to Medical Device Development Success

Medical Device Development SuccessIn my experience, a product’s best chance at successful commercialization is to ensure it follows a Five Step Development process. Company value, and user safety will rely on the due diligence required within each step of the process. The engineers who develop these frameworks live and breathe Murphy’s epigram, “Anything that can go wrong will go wrong”. Your investors and customers will thank you.

Continue reading »

Nigel Syrotuck

How to Conduct Particulate Pre-Testing for ISO 18562-2:2017

Pre-Testing for ISO 18562-2:2017Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process standard. In this blog I will share our approach from my engineering perspective.

Continue reading »

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks